Clinical data management (CDM) for Productive, Qualitative data collection
In today’s competitive era, the biopharmaceutical industry has been facing the challenge, both internally and externally, for increasing productivity. Using effective technology-enabled methods to manage clinical data can enhance the speed with which the drug is developed and commercialized, which enhance the competitive advantage. In such conditions CDM helps in reduction of time from drug development to marketing.
The clinical data management is a well-defined, well designed and well controlled process of managing the clinical trial data. The clinical trial is intended to proving or disproving a hypothesis by means of generating the data. The Clinical Data Management refers to the management of data capture and data flow processes in conduct of a clinical trial. The clinical data quality and integrity both are very crucial and plays an important role in the outcome of the clinical study. All the drug developers want to ensure the reliability to regulatory bodies for the delivered data, as clinical data information helps in treatment decisions making, thereby ultimately affecting the patient health. CDM evolves from a data entry process to a diverse process which is an essential to the integrity of a clinical trial. The CDM manages all like entry of CRF data, merging of non-CRF data, generate and track CRF, systems and processes designed to identify the ill-processed data, determine the protocol violators and interact with the site personnel to resolve the data issues. Now it is very clear that clinical research is impossible without the use of Clinical Data Management Systems (CDMS).
The clinical data management and the use of EDC systems in clinical trials are characterized by the impact of regulations and guidelines. CDM also works in different fields including the data collection, CRF tracking, CRF annotation, database design, data validation, medical coding, data entry, discrepancy management and database lock. CDM team consists of individuals with skills such as technical, scientific, project management, information technology, systems engineering and interpersonal skills to tackle, drive, and provide valued service in managing data. The team members of CDM are actively involved in all the stages of clinical trial right from inception to the completion. Software tools available as Clinical Data Management Systems (CDMS), are very essential to handle the huge amount of data in multi-centric clinical trials. Most of these CDMS software tools are more or less similar and there is no significant advantage of one system over the other software system. In the clinical development process, clinical data is recognized as the key corporate asset which provides critical evidence of the medicine’s efficacy and safety and its potential economic value to the market. Hence in today’s competitive pharmaceutical industries it has become very clear that the Clinical data management (CDM) is a vital functional vehicle in the clinical trials.
At WorkSure®, with an integrated customized technology driven and user friendly interface, we ensure efficient delivery. We offer multiple flexible solutions to meet fast analysis and management of the data without compromising its integrity and accuracy. In completion of the clinical development process, we use multiple tools for adherence to the compliance standards. We assure the highest quality and rapid data collection and distribution to sponsors and better traceability of data and robust QC at database lock. Our cost elastic model and habit of meeting timelines help us deliver the best clinical data outcomes.